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Sodium/Potassium Conditioning Solution

by Hi Chem, Inc.

510(k) K791691

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791691 Date17 Sep 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JGS
Device Class
Class II
Regulation
21 CFR Part 862.1665
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sodium/Potassium Conditioning Solution is an electrode, ion specific, sodium device. It is classified as a Class II device with special controls. The device is used in clinical chemistry applications.

The Sodium/Potassium Conditioning Solution is supplied by Hi Chem, Inc. and has been cleared by the FDA with a 510(k) number of K791691. The device is regulated under the product code JGS and has a regulation number of 862.1665. It is intended for use in a clinical setting and is subject to special controls as a Class II device.

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